In application of Regulation (EC) No 273/2004, Council Regulation (EC) No 111/2005, Commission Delegated Regulation (EU) 2015/1011, (EU) 2015/1013 and Commission Delegated Regulation (EU) 2016/1443) and (EU)2018/729, operators shall hold a licence/registration when:
- engaged in import, export or intermediary activities, possession and/or placement on the market of substances category 1;
- in possession of substance Category 2A and /or placement on the market of scheduled substances listed in Category 2 in the EU;
- engaged in the import or export or intermediary activities involving of scheduled substances listed in Category 2 or engaged in the export or intermediary activities involving of scheduled substances listed in Category 3.
New request
The request can only be made through this application form.
The licence/registration is valid for 3 years and can be renewed.
Modification
Any change to the data stated on the licence/registration must be reported to the FAMHP within ten working days.
If it appears that the licence/registration contains incorrect data because changes were not reported to the FAMHP, the licence/registration may be withdrawn or temporarily suspended.
The request for change can only be made via this application form. Please also return the original of the current licence.
In case of a name change, a completely new application must be submitted. A new licence with a new number will be issued.
Renewal
At least three months before the expiry of the licence/registration, a renewal application must be submitted to the Precursors Unit using this renewal form. Please also return the original of the current licence.
Please complete the application form in full and add the necessary signatures and annexes, otherwise the application will be declared inadmissible. The application form and any supporting documents may be sent
- by post to:
Federal Agency for Medicines and Health Products
DG Inspection - Authorisations Divison - Drug Precursors Unit
Avenue Galilée 5/03
1210 Brussels
- By e-mail to:
Only when provided with qualified electronic signatures (NO SCAN).
Fees
A fee is charged by the FAMHP for the application and renewal of a licence/registration. This fee will be indexed annually.
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New application for licence / registration |
€ 342,78
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Renewal |
€ 342,78
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The fee is not to be paid in advance, but will be invoiced when the licence/registration, or renewal is delivered.